17.03.2006 12:03:00
|
Hana Biosciences to License Three Targeted Cancer Drug Candidates from Inex Pharmaceuticals
-- Hana plans to initiate pivotal trials for Marqibo(TM) (sphingosomal vincristine) in hematological malignancies in 2006.
-- Sphingosomal vinorelbine targeted to start clinical trials in 2006, and sphingosomal topotecan in 2007.
-- Proprietary sphingosomal platform doubles Hana's oncology pipeline to six clinical stage drugs.
Hana Biosciences (AMEX:HBX) signed a letter of intent to licensethe worldwide rights to develop and commercialize three novel targetedchemotherapy drug candidates for the treatment of solid andhematological cancers from Inex Pharmaceuticals Corporation (TSX:IEX).The three candidates are known as Marqibo(TM) (sphingosomalvincristine), sphingosomal vinorelbine, and sphingosomal topotecan.Marqibo(TM) (sphingosomal vincristine) has demonstrated promisingactivity in patients with non-Hodgkin's lymphoma (NHL) and acutelymphoblastic leukemia (ALL) in completed and ongoing studies.
The novel targeted formulation of these approved chemotherapeuticagents is designed to significantly increase drug delivery to thetumor and prolong drug exposure for cell-cycle specific agents, thusincreasing dose intensity. Based on completed and ongoing studies inhematological cancers, these innovative products may deliver higherdrug doses into the tumor, with concomitant increases in clinicalactivity.
"This transaction will enhance Hana's portfolio of novelanticancer compounds, underscoring our patient-focused commitment tocommercializing novel oncology therapies. We look forward to workingwith the FDA to obtain the Special Protocol Assessment (SPA) inhematological cancers, and to initiating registrational trials forMarqibo(TM) in 2006, while our current clinical programs continue onschedule," said Mark Ahn, PhD, President and CEO, Hana Biosciences.
Timothy M. Ruane, President and CEO of INEX, stated: "The team atHana has a strong track record in oncology drug development, and ourtargeted chemotherapy products are a perfect fit in their pipeline. Wewill support their efforts as they move Marqibo(TM) towardscommercialization and continue the development of sphingosomalvinorelbine and sphingosomal topotecan."
Under the terms of the transaction, Hana will pay INEX a total of$11.5 million upon closing, consisting of cash and shares of Hanacommon stock. In addition, Hana will pay INEX up to $30.5 million inshares of Hana common stock, contingent upon achievement of specificclinical and regulatory milestones, and royalties on net sales. Thecompletion of the transaction is subject to the execution ofdefinitive agreements, as well as other customary closing conditions,which are expected to be completed in the second quarter of 2006.Canaccord Adams is acting as the exclusive financial advisor to Hanain the transaction.
This licensing transaction will double Hana's pipeline to sixclinical-stage oncology compounds. The drug candidates included in thetransaction are:
-- Marqibo(TM) (sphingosomal vincristine) was previously studied in Phase II trials in non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL). Marqibo(TM) is targeted to enter pivotal trials in 2006, after a Special Protocol Assessment (SPA) is completed with the FDA.
-- Sphingosomal vinorelbine, for which an IND application is approved both in the US and Canada, is planned to enter clinical trials in 2006.
-- Sphingosomal topotecan, based on a unique formulation which significantly enhances activity in pre-clinical models, is planned to enter clinical trials in 2007.
The intellectual property covering the three product candidates isprotected worldwide until 2020 by issued and pending patents.
"Vincristine is a cornerstone of combination chemotherapy inlymphoproliferative diseases. We believe that by raising the dose ofthis drug we can improve its clinical activity. The increased dose andpromising activity of sphingosomal vincristine in patients with NHLand ALL support moving this drug into registrational trials," said Dr.Hagop Kantarjian, MD, Professor and Chairman of the LeukemiaDepartment at the M.D. Anderson Cancer Center.
Hana to host a conference call on March 20, 2006 at 4:30 PM ET
Hana Biosciences will discuss the proposed transaction, as well asrecently released results of operations and an overview of 2006 goals,in a teleconference at 4:30 PM ET on Monday, March 20, 2006. Thoseinterested in hearing management's discussion may join the call bydialing 877-407-9210. International participants may access the callby dialing 201-689-8049. Participants may also access a liveweb-cast of the conference call through the Investor Relations sectionof Hana's website at www.hanabiosciences.com.
A replay will be available for three months following the call bydialing 877-660-6853 for domestic participants and 201-612-7415for international participants and entering 286 for the playbackaccount number and 196499 for the playback access code when prompted.
About Sphingosomal Targeted Drug Delivery
Sphingosomal encapsulation is a new generation liposomal drugdelivery platform, which significantly increases tumor targeting andduration of exposure for cell cycle-specific anticancer agents.Sphingosomal drug delivery consists of using an already approvedcancer agent encapsulated in a lipid envelope. The encapsulated agentis carried through the bloodstream and delivered to disease siteswhere it is released to carry out its therapeutic action.
When used in unencapsulated form, chemotherapeutic drugs diffuseindiscriminately throughout the body, diluting drug effectiveness andcausing toxic side effects in the patient's healthy tissues. Theproprietary sphingosomal formulation technology permits the loading ofa high concentration of therapeutic agent inside the lipid envelope,promotes accumulation of the drug in tumors and prolongs the releaseof the drug at disease sites. As a result, compared to unencapsulateddrugs, agents encapsulated in sphingosomes have been shown to delivermore of the therapeutic agent to a targeted disease site over a longerperiod of time, thus increasing the efficacy of the drug withoutincreasing the toxicity in healthy, non-targeted tissues.
-- Longer circulation time in plasma delivers more of the therapeutic agent to targeted tumor sites over a longer period of time. To stabilize the lipid bilayer walls and retain active drug within the aqueous interior, this new generation liposomal technology uses sphingomyelin, a safe, biologically inert macromolecule whose amide backbone is resistant to hydrolysis. The increased rigidity of the liposomal walls prolongs the circulating life of liposomes and significantly extends the duration of drug release.
-- Sphingosomal drugs like Marqibo(TM) readily extravasate through the pores of leaky tumor vessels created during angiogenesis and readily accumulate within the tumor. In normal tissues, a continuous endothelial lining constrains liposomes within capillaries, preventing accumulation of the drug in the interstitial space. In contrast, the immature neovasculature within tumors is created during angiogenesis and has numerous imperfections, pores and discontinuities up to 800 nm in size. With an average diameter of approximately 100 nm, sphingosomes readily extravasate through these pores and accumulate within the tumor. Once lodged within the interstitial space, these resilient sphingosomes slowly release the encapsulated drug. Slow release of the drug from extravasated sphingosomes increases drug levels within the tumor, extends drug exposure through multiple cell cycles, and significantly enhances tumor cell killing. Vincristine kills tumor cells as they pass through a sensitive phase of cell division, but fewer than 5% of a patient's tumor cells are in this sensitive phase at any point in time. The duration of drug exposure is therefore critical to increased clinical activity.
-- Increased drug concentration at the tumor site is associated with increased clinical activity. The link between drug exposure and anti-tumor efficacy is especially pronounced for cell cycle-specific agents such as vincristine, vinorelbine and topotecan, which kill tumor cells by interfering with mitosis at a precise step during the cancer cell cycle. Thus, this proprietary sphingosomal drug delivery platform encapsulates approved anticancer agents within the aqueous interior of small liposomes to potentially enhance the therapeutic index of these existing anticancer treatments.
About Vincristine, Vinorelbine, and Topotecan
Sphingosomal products such as Marqibo(TM) (sphingosomalvincristine) are loaded with active, cell cycle-specific anticanceragents that may benefit from increased targeting and long duration ofdrug exposure at the tumor site. Vincristine, vinorelbine andtopotecan are approved cancer therapies which have been selected forsphingosomal formulation specifically for their ability to benefitfrom this novel encapsulation:
-- Vincristine (Oncovin(R); Eli Lilly & Company), a microtubule inhibitor, is approved for acute lymphoblastic leukemia (ALL) and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias.
-- Vinorelbine (Navelbine(R); GlaxoSmithKline), a microtubule inhibitor, is approved for use as a single agent or in combination with cisplatin for the first-line treatment of unresectable, advanced non-small cell lung cancer.
-- Topotecan (Hycamtin(R); GlaxoSmithKline), a topoisomerase I inhibitor, is approved for use in relapsed small-cell lung cancer and in relapsed ovarian cancer.
About Non-Hodgkin's Lymphoma (NHL) and Acute LymphoblasticLeukemia (ALL)
Non-Hodgkins lymphoma (NHL) is a heterogeneous disease whichresults in approximately 50,000 new cases and almost 25,000 deathsannually in the United States. NHL usually originates in lymphoidtissues and can spread to other organs. The prognosis depends on thehistologic type, stage, and treatment. The NHLs can be divided into 2prognostic groups: indolent lymphomas and aggressive lymphomas.Indolent NHL types have a relatively good prognosis, with mediansurvival as long as 10 years, but they usually are not curable inadvanced clinical stages. The aggressive type of NHL has a shorternatural history, but a significant number of these patients can becured with intensive combination chemotherapy regimens which includeagents such as vincristine. With modern treatment, overall five-yearsurvival of NHL patients is approximately 50% to 60%. Of patients withaggressive NHL, 30% to 60% can achieve durable remission. The vastmajority of relapses occur in the first two years after therapy andnew therapeutic options are needed.
Acute lymphoblastic leukemia (ALL) is a type of cancer of theblood and bone marrow -- the spongy tissue inside bones where bloodcells are made. Acute leukemias progress rapidly and affect immatureblood cells, rather than mature ones. Acute lymphoblastic leukemiaaffects a group of white blood cells called lymphocytes, which fightinfection. Normally, bone marrow produces immature cells (stem cells)in a controlled way, and they mature and specialize into the varioustypes of blood cells, as needed. In people with ALL, this productionprocess goes awry. Large numbers of immature, abnormal lymphocytescalled lymphoblasts are produced and released into the bloodstream.These abnormal cells aren't able to mature and perform their usualfunctions. Furthermore, they multiply rapidly and can crowd outhealthy blood cells, leaving an adult or child with ALL vulnerable toinfection or easy bleeding. Leukemic cells can also collect in certainareas of the body, including the central nervous system and spinalcord, which can cause serious problems. Almost 4,000 Americans arediagnosed with acute lymphoblastic leukemia each year. This form ofcancer worsens quickly if not treated, but it usually responds well toinitial treatment. Adults have a 30% to 50% cure rate, underscoringthe need for new therapeutic options.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (AMEX:HBX) is a South San Francisco,CA-based biopharmaceutical company that acquires, develops, andcommercializes innovative products to advance cancer care. The companyis committed to creating value by building a world-class team,accelerating the development of lead product candidates, expanding itspipeline by being the alliance partner of choice, and nurturing aunique company culture. Additional information on Hana Biosciences canbe found at www.hanabiosciences.com
About Inex Pharmaceuticals Corporation
INEX is a Canadian biopharmaceutical company developing andcommercializing proprietary drugs and drug delivery systems to improvethe treatment of cancer. Since 1996, INEX common shares have beentrading on the Toronto Stock Exchange under the symbol "IEX".Additional information on INEX can be found at www.inexpharm.com.
This press release contains forward-looking statements within themeaning of the Private Securities Litigation Reform Act of 1995. Suchstatements involve risks and uncertainties that could cause Hana'sactual results to differ materially from the anticipated results andexpectations expressed in these forward-looking statements. Thesestatements are based on current expectations, forecasts andassumptions that are subject to risks and uncertainties, which couldcause actual outcomes and results to differ materially from thesestatements. Among other things, there can be no assurances that Hanawill be able to complete the proposed transaction with INEX or thatany of Hana's development efforts relating to its product candidates,as well as those to be licensed from INEX, will be successful. Otherrisks that may affect forward-looking information contained in thispress release include the possibility of being unable to obtainregulatory approval of Hana's product candidates, the risk that theresults of clinical trials may not support Hana's claims, Hana'sreliance on third-party researchers to develop its product candidates,and its lack of experience in developing pharmaceutical products.Additional risks are described in the company's Annual Report on Form10-K for the year ended December 31, 2005. Hana assumes no obligationto update these statements, except as required by law.
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!
Nachrichten zu IDEX Corp.mehr Nachrichten
Analysen zu IDEX Corp.mehr Analysen
Aktien in diesem Artikel
IDEX Corp. | 200,10 | -0,30% |
Indizes in diesem Artikel
S&P 600 SmallCap | 935,46 | -0,94% |